Universal reference book for medicines
Name of the preparation: CERULOPLASMIN (CERULOPLASMIN)

Active substance: nonappropriate

Type: Erythropoiesis stimulant

Producer: NGO MIKROGEN (Russia) branch IMMUNOPREPARAT (Russia)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration of
blue color.

1 amp.

ceruloplasmin (copper-containing enzyme alpha- 2- globulin fraction of blood serum derived from human plasma) 100 mg

100 mg - ampoules (5) - packs of cardboard.

100 mg - ampoules (10) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Detoxifying agent.
Performs in the body a number of important functions: it is the main carrier of copper in the body; participates in the metabolism of iron; is an antioxidant, binds superoxide radicals and prevents peroxide oxidation of lipids of cell membranes, increases the stability of cell membranes; accelerates the replacement of the number of erythrocytes in the treatment of anemia of various etiologies, has a protective effect on both erythroid and on myeloid and lymphoid hematopoietic elements; participates in immune reactions; participates in ion exchange; reduces intoxication and immunodepression in the treatment of diseases associated with the use of chemotherapy and radiotherapy.
INDICATIONS

- Anemia of different genesis in adults and children (over 6 months);

- Lakopenia;

- cachexia;

- intoxication;

- in the complex therapy of cancer patients;

- preoperative preparation in weakened patients with anemia;

- massive and moderate blood loss during surgery;

- purulent-septic complications in the early postoperative period;

- osteomyelitis (acute and chronic).

DOSING MODE

In / in the drip with the speed in adults 30 drops / min, in children 40-50 drops / min.
The contents of one ampoule are dissolved in 200 ml of 0.9% sodium chloride solution. Do not exceed the indicated rate of administration. The drug is used in a hospital.
The following dosages are recommended.

Oncological patients in the period of preoperative preparation of Ceruloplasmin are administered in a dose of 1.5-2.0 mg / kg body weight / day;
course of treatment 7-10 intravenously, every day or every other day, depending on the patient's condition.
In the postoperative period, a single dose is determined by the amount of blood loss and is from 1.5 mg / kg with moderate blood loss, up to 6 mg / kg in case of massive blood loss.
The course of treatment consists of daily (1 time / day) IV injections for 7-10 days.
When conducting radiotherapy and chemotherapy, a single dose is 4-6 mg / kg of body weight, the course of treatment consists of 10-14 intravenous injections (3 injections per week).

For patients with hemoblastoses, the single dose is 1.5-3.0 mg / kg, the course of treatment is 7-10 intravenous infusions, administered daily 1 time / day.

In acute osteomyelitis, a single dose of 2.5 mg / kg of body weight, the course of treatment consists of 5 intravenous administrations, administered daily or every other day.
In chronic osteomyelitis, Ceruloplasmin is administered at 5 mg / kg 2-3 times at intervals of 1-2 days, and then 3-7 injections of 2.5 mg / kg are given.
In pediatric practice, the following dosages are recommended:

- Children from 6 months to 1 year - 50 mg (100 ml of solution);

- from 1 year to 12 years - 100 mg;

- from 13 to 18 years - 200 mg.

For the prevention and / or treatment of posthemorrhagic anemia in surgical operations in children, Ceruloplasmin is administered within 2 days prior to surgery, intraoperatively and within 2-10 days after surgery.

For the prevention and / or treatment of anemia in children with purulent-surgical diseases, Ceruloplasmin is administered for 7-10 days daily on the days of antibiotic therapy.

In children with cancer, for the prevention and / or treatment of radiation anemia with radiation therapy, Ceruloplasmin is administered once a week throughout the course of radiotherapy;
for the prevention and / or treatment of toxic anemia Ceruloplasmin is administered on chemotherapy days throughout the course; To prevent and treat toxic and radiation anemia on the background of chemoradiotherapy, Ceruloplasmin is administered once a week on the day of chemotherapy throughout the course of treatment.
SIDE EFFECT

At the beginning of treatment, there may be a sensation of blood flow to the face, nausea, chills, short-term fever, skin rashes (urticaria).
In these cases, it is necessary to reduce the dose of the drug, reduce the rate of administration, or cancel the drug.
CONTRAINDICATIONS

- Children's age from 0 to 6 months (due to the lack of data on efficacy and safety of use in this category of patients);

- hypersensitivity to drugs of protein origin.

PREGNANCY AND LACTATION

It is used in the complex therapy of anemia in the II and III trimesters of pregnancy.
Against the background of the appointment of iron preparations (taking into account the parameters of serum iron and ferritin), additionally appoint Ceruloplasmin 100 mg daily iv drip for 5 days.
It is not recommended to administer the drug in the first trimester of pregnancy and during lactation (due to the lack of efficacy data and safety of use in this category of patients).

APPLICATION FOR CHILDREN

Contraindicated in children from 0 to 6 months (due to the lack of data on efficacy and safety of use in this category of patients).

In pediatric practice, the following dosages are recommended:

- Children from 6 months to 1 year - 50 mg (100 ml of solution);

- from 1 year to 12 years - 100 mg;

- from 13 to 18 years - 200 mg.

For the prevention and / or treatment of posthemorrhagic anemia in surgical operations in children, Ceruloplasmin is administered within 2 days prior to surgery, intraoperatively and within 2-10 days after surgery.

For the prevention and / or treatment of anemia in children with purulent-surgical diseases, Ceruloplasmin is administered for 7-10 days daily on the days of antibiotic therapy.

In children with cancer, for the prevention and / or treatment of radiation anemia with radiation therapy, Ceruloplasmin is administered once a week throughout the course of radiotherapy;
for the prevention and / or treatment of toxic anemia Ceruloplasmin is administered on chemotherapy days throughout the course; To prevent and treat toxic and radiation anemia on the background of chemoradiotherapy, Ceruloplasmin is administered once a week on the day of chemotherapy throughout the course of treatment.
SPECIAL INSTRUCTIONS

In extremely rare cases, individuals with altered reactivity to blood products may develop anaphylactic shock, and therefore all persons who receive the drug should be under medical supervision.
In the room where the drug is administered, there should be antishock therapy. The preparation should be registered in the prescribed registration forms with the name of the product, serial number, date of manufacture, expiration date, manufacturer's company, date of administration and adverse reactions to the drug administration.
DRUG INTERACTION

With the introduction of the drug use a separate system for intravenous administration.
Used in complex therapy with other drugs.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Keep the drug at a temperature of 2 ° to 8 ° C out of the reach of children.

Shelf life - 2 years.

Do not use after expiry date.

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